BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2043140 · Received February 24, 2011

    Report

    Report Number
    1219856-2011-00078
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "A FEW WEEKS AGO" WHILE IN THE CATH LAB, THE MD INSERTED AN IAB VIA A SHEATH INTO THE PT'S FEMORAL ARTERY. THE TECHNICIANS WERE UNABLE TO GET AN AP (ARTERIAL PRESSURE) READING FROM THE IAB TO THE PUMP, ALTHOUGH THEY SAID THE IAB WAS INFLATING & DEFLATING. THEY TRIED TROUBLESHOOTING THE TRANSDUCER & CENTRAL LUMEN & WERE UNABLE TO DETERMINE THE PROBLEM. THEY THEN RETRIEVED A SECOND PUMP & HOOKED THE FIRST IAB UP TO IT. THEY GOT AN AP READING, BUT THE IAB WAS NOT INFLATING & DEFLATING. THEY DETERMINED THIS BECAUSE THEY COULD SEE THE LACK OF INFLATION UNDER FLUOROSCOPY & ALSO BECAUSE THE BPW (BALLOON PRESSURE WAVEFORM) DID NOT INDICATE INFLATION. THERE WAS ALSO NO AUGMENTATION. WHEN THE SALES REP ASKED THE TECHNICIANS LATER, THEY THOUGHT PERHAPS THE VOLUME OF THE IAB WAS INDICATING 2.5CC & NOT 40 CC. AT THIS POINT, THEY REMOVED THE IAB & REPLACED IT WITH A SECOND IAB (WHICH THEY HOOKED UP TO THE SECOND PUMP). THIS TIME THE IAB STARTED TO INFLATE & THEY WERE ABLE TO GET AN AP WAVEFORM. THEY DID NOT SAVE THE FIRST IAB. REFERENCE MDR # 1219856-2011-00079 FOR THE INTRA-AORTIC BALLOON (IAB) REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INTRA-AORTIC BALLOON